QEO

Light Attenuation Lenses For Migraine-Associated Light Sensitivity

产品代码

QEO

器械名称

Light Attenuation Lenses For Migraine-Associated Light Sensitivity

管理类别

第 1 类（Class I）

21 CFR 条款

21 CFR 882.5811

FDA 专业组

Neurology

上市路径

豁免 510(k)（仍须遵守通用控制与注册列名）

该代码近三年的 510(k)

1 件

FDA 分类定义

Light attenuation lenses for migraine-associated light sensitivity are devices that limit light incidence of specific wavelengths to the eyes and are intended to decrease the impact of light sensitivity in patients diagnosed with migraine. The lenses can be mounted on a spectacle frame, clips, or other apertures used to hold lenses. The device is intended to be adjunctive to other therapies for migraine-associated light sensitivity. Sunglasses (nonprescription) and prescription spectacle lenses are separately classified under § 886.5850 and § 886.5844, respectively.

定义原文来自 FDA 器械分类库，属美国联邦政府作品（公有领域）。

该代码近三年的 510(k)（1 件）

数据窗口为最近三年。最新一件：2026-08-21。